A study of Osimertinib with or without Chemotherapy as 1st line Treatment in Patients with mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) - FLAURA2

Study identifier:D5169C00001

ClinicalTrials.gov identifier:NCT04035486

EudraCT identifier:2019-000650-61

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, Open-label, Randomized Study of Osimertinib with or without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients with Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Osimertinib, Pemetrexed/Carboplatin, Pemetrexed/Cisplatin

Sex

All

Actual Enrollment

587

Study type

Interventional

Age

18 Years - 110 Years

Date

Study Start Date: 02 Jul 2019
Primary Completion Date: 03 Apr 2023
Estimated Study Completion Date: 03 Jun 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria